To produce from EPA-grade drinking water, sterile purified water to be used within 24-hours of collection that is suitable for: - cleaning and rinsing open wounds; - infection control (cleaning equipment used in medical procedures, medical personnel's hands); - use as a diluent for enteral, nutritional, oral vaccine or oral drug preparations; and - all other uses of sterile purified water the practitioner, or clinician deems necessary. - Not for parenteral administration.
Device Story
MainStream™ Water Purification Device is a single-use system that processes approximately 3000 mL of EPA-grade drinking water into USP-grade sterile purified water. The device utilizes a multi-stage filtration and purification process, including prefiltration, depth filtration, deionization, and sterilizing membrane filtration. It is intended for use by clinicians or practitioners in medical settings to provide water for wound care, equipment cleaning, and as a diluent for non-parenteral preparations. The output is sterile water that must be used within 24 hours of collection. The device benefits patients and clinicians by providing a point-of-use source of sterile water for various medical procedures.
Clinical Evidence
Bench testing only. The device's safety and effectiveness were demonstrated by verifying that the end-product water meets the quality attributes and compendial standards of USP Sterile Purified Water, consistent with the predicate device.
Technological Characteristics
Single-use water purification device. Purification stages: prefiltration, depth filtration, deionization, and sterilizing membrane filtration. Produces USP-grade sterile purified water from EPA-grade drinking water. 260-mL device size provides up to 3 liters of output. Mechanical/physical filtration principle; no software or electronic components.
Indications for Use
Indicated for clinicians/practitioners requiring sterile purified water for wound cleaning/rinsing, infection control (equipment/hand cleaning), and as a diluent for enteral, nutritional, oral vaccine, or oral drug preparations. Not for parenteral administration.
Regulatory Classification
Identification
A water purification system for hemodialysis is a device that is intended for use with a hemodialysis system and that is intended to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form dialysate. This generic type of device may include a water softener, sediment filter, carbon filter, and water distillation system.
Special Controls
*Classification.* Class II (special controls). The device, when it is a water purification subsystem disinfectant, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
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MAY 0 7 2002
K012716
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# 510(K) SUMMARY
As required by 512(1)(3)(A) of the Food, Drug and Cosmetic Act, PrISMedical Corporation is required to submit with this Premarket Notification either an " ... adequate summary of any information respecting safety and effectiveness or state that information will be made available upon request of any person." PrISMedical chooses to submit a summary of safety and effectiveness information.
| Applicant | PrISMedical Corporation<br>1100 Trancas Street, Suite 250<br>Napa, CA 94558<br>Phone: (707) 258-8666<br>FAX: (707) 258-0115<br>Contact Person: Elaine Alambra |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Tradename | MainStream™ Water Purification Device |
| Device Generic Name | Water Purification Device |
| Classification / Classification Name | To be determined |
| Predicate Device | Total Water Treatment Systems (TWTS) – K002045 |
| Product Description | PrISMedical's MainStream™ Water Purification Device (WPD) is a single-use device that will take approximately 3000 mL of drinking water (EPA-grade or equivalent) and remove:<br><ul><li>particulates</li><li>dissolved solids</li><li>organics and inorganics</li><li>microbial contaminants</li><li>endotoxins</li></ul> |
PRISMEDICAL CORPORATION
510(K) SUMMARY - K012716
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K01276
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to produce water that meets the quality attributes of USP sterile purified water. This device comes in a 260-mL size to provide up to 3-liters of Sterile Purified Water, USP.
The device incorporates several complementary processes:
- Prefiltration .
- Depth filtration .
- Deionization .
- Sterilizing membrane filtration ●
To produce from EPA-grade drinking water, sterile purified water to be used within 24 hours of collection that is suitable for:
- cleaning and rinsing open wounds; .
- infection control (cleaning equipment used . in medical procedures, medical personnel's hands);
- use as a diluent for enteral, nutritional, oral � vaccine, or oral drug preparations; and
- all other uses of sterile purified water the . practitioner or clinician deems necessary.
- ◆ Not for parenteral administration.
Safety and functionality for this device were based solely on end product water characteristics. The materials, performance specifications and essential design characteristics of PrISMedical's MainStream™ water purification device are essentially identical to those of the Total Water Treatment Systems (TWTS) - K002045 predicate device. Both devices produce water
Intended use
Safety and Performance
PRISMEDICAL CORPORATION
510(K) SUMMARY - K012716
PAGE 2 of 3
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K012716
Page 3 of 3
that meets the standards of USP Sterile Purified Water.
Conclusion
Based on the results of our testing and comparison of the requirements of the end product of the predicate device to compendial standards (Sterile Purified Water, USP), PrISMedical's MainStream™ Water Purification Device has been shown to be safe and effective for its intended use.
### 510(K) SUMMARY - K012716
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## DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the eagle.
#### Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Elaine Alambra Director, RA/QA PrISMedical Corporation 1100 Trancas Street NAPA CA 94558
MAY 0 7 2002
Re: K012716
Trade/Device Name: PrISMedical's MainStream™ Water Purification Device (WPD) Regulation Number: 21 CFR 876.5665 Regulation Name: Water purification system for hemodialysis
Regulatory Class: II Product Code: 78 NHV Dated: March 7, 2002 Received: March 11, 2002
Dear Ms. Alambra:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmaldsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
# 510(k) Number (if known): K012716
Device Name:
Indications for Use:
MainStream™ Water Purification Device
To produce from EPA-grade drinking water, sterile purified water to be used within 24-hours of collection that is suitable for:
- cleaning and rinsing open wounds; .
- infection control (cleaning equipment used in . medical procedures, medical personnel's hands);
- use as a diluent for enteral, nutritional, oral . vaccine or oral drug preparations; and
- all other uses of sterile purified water the . practitioner, or clinician deems necessary.
- Not for parenteral administration. .
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
**Prescription Use**
(Per 21 CFR 801.109)
Nancyc brogdon
K812916
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
